Percutaneous Mechanical Thrombectomy for Deep Vein Thrombosis
(PROTECTOR Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen BySabah D Butty, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inari Medical
Must not be taking: Heparin
Disqualifiers: Pregnancy, Severe hypertension, Renal impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, your INR (a blood test that measures how long it takes blood to clot) should be considered, and therapeutic anticoagulation must be possible according to the investigator's discretion.
What data supports the effectiveness of the treatment Protrieve Sheath for deep vein thrombosis?
The Protrieve Sheath was successfully used in a case where it helped remove a blood clot during a procedure for deep vein thrombosis without any complications, suggesting it may improve the safety of such treatments.
12345Is percutaneous mechanical thrombectomy safe for humans?
Research shows that percutaneous mechanical thrombectomy is generally safe for treating deep vein thrombosis and pulmonary embolism, with low rates of major bleeding events and mortality. However, as with any medical procedure, there are risks, and further studies are needed to fully understand its safety profile.
678910How is the Protrieve Sheath treatment different from other treatments for deep vein thrombosis?
The Protrieve Sheath is unique because it is designed to trap and remove blood clots during the procedure, reducing the risk of complications like embolization (when a clot travels to another part of the body). This makes it potentially safer for treating complex cases of deep vein thrombosis that extend into the inferior vena cava (a large vein that carries blood to the heart).
134911Eligibility Criteria
Adults over 18 with specific blood clot conditions like bilateral iliofemoral deep vein thrombosis, clots in the inferior vena cava (IVC), in-stent thrombosis, or a blocked IVC filter. Participants should be at high risk for blood clots traveling through the bloodstream and must consent to join.Inclusion Criteria
I am 18 years old or older.
Willing and able to provide informed consent
I am at high risk for blood clots in my lungs and need treatment.
Exclusion Criteria
My blood clotting and platelet levels are not within safe ranges for this trial.
Subject is pregnant
Subject is participating in another study that may interfere with this study
+13 more
Participant Groups
The study is testing the Protrieve Sheath, a device used in percutaneous mechanical thrombectomy (PMT) to remove blood clots from within the heart's sac or arteries and veins without surgery.
1Treatment groups
Experimental Treatment
Group I: Protrieve SheathExperimental Treatment1 Intervention
The Protrieve Sheath is intended for embolic protection in the inferior vena cava (IVC) to prevent clinically significant intraprocedural pulmonary embolism during mechanical thrombectomy procedures in patients with high risk of embolization.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
MedStar Union Memorial HospitalBaltimore, MD
Englewood HospitalEnglewood, NJ
Hospital of the University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Inari MedicalLead Sponsor
References
[Analysis of clinical therapeutic effect using percutaneous mechanical thrombectomy in the treatment of acute deep venous thrombosis]. [2018]To evaluate the use of percutaneous mechanical thrombectomy in the treatment of acute deep venous thrombosis.
Percutaneous AngioJet thrombectomy in the management of extensive deep venous thrombosis. [2022]This study was undertaken to evaluate the efficacy of a percutaneous mechanical thrombectomy (PMT) device for rapid thrombus removal following deep venous thrombosis (DVT).
Mechanical thrombectomy in patients with deep venous thrombosis. [2019]To report our experience with mechanical thrombectomy in proximal deep vein thrombosis (DVT).
Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis. [2023]Extension of proximal deep vein thrombosis (DVT) into the inferior vena cava (IVC) complicates treatment with mechanical thrombectomy, as the presence of IVC thrombus increases embolization risks. In the case of a 39-year-old man with left-sided iliocaval DVT, the novel Protrieve sheath (Inari Medical, Irvine, California) was intraprocedurally placed in the IVC to ensure such complications would not outweigh the benefits of intervention. During successful thrombectomy, the sheath's wall-apposing funnel trapped and removed procedural embolus from the IVC, with no complications occurring. Studies to determine whether the device can broadly improve the safety of complex DVT procedures are warranted.
Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review. [2022]Pulmonary embolism (PE) is one of the most common causes of cardiovascular (CV) mortality worldwide. Owing to the associated morbidity and mortality with other treatment modalities, including systemic thrombolysis, a discernible change in the era of acute pulmonary embolism management has been reported. Catheter-directed thrombectomy using the FlowTriever system (Inari Medical; Irvine, CA, USA) was shown to reduce endpoints of interest in patients with acute intermediate-high risk PE and was associated with rapid hemodynamic improvement. In this report, we describe our experience with three cases of patients presenting with submassive PE, whereby immediate pulmonary artery pressure improvement was evident in all cases after successful mechanical thrombectomy. Our experience supports the use of FlowTriever mechanical thrombectomy for the treatment of submassive PE in clinical practice, with a call for further research to establish associated benefits.
A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. [2020]The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis. [2023]Catheter-directed interventions have slowly been gaining ground in the treatment of pulmonary embolism (PE), especially in patients with increased risk of bleeding. The goal of this study is to summarize the evidence for the efficacy and safety of percutaneous thrombectomy (PT) in patients with contraindications to systemic and local thrombolysis. We performed a systematic review and meta-analysis using MEDLINE, Cochrane, Scopus and the Web of Science databases for studies from inception to March 2022. We included patients with intermediate- and high-risk PE with contraindications to thrombolysis; patients who received systematic or local thrombolysis were excluded. Primary endpoint was in-hospital and 30-day mortality, with secondary outcomes based on hemodynamic and radiographic changes. Major bleeding events were assessed as a safety endpoint. Seventeen studies enrolled 455 patients, with a mean age of 58.6 years and encompassing 50.4% females. In-hospital and 30-day mortality rates were 4% (95% CI 3-6%) and 5% (95% CI 3-9%) for all-comers, respectively. We found a post-procedural reduction in systolic and mean pulmonary arterial pressures by 15.4 mmHg (95% CI 7-23.7) and 10.3 mmHg (95% CI 3.1-17.5) respectively. The RV/LV ratio and Miller Index were reduced by 0.42 (95% CI 0.38-46) and 7.8 (95% CI 5.2-10.5). Major bleeding events occurred in 4% (95% CI 3-6%). This is the first meta-analysis to report pooled outcomes on PT in intermediate- and high-risk PE patients without the use of systemic or local thrombolytics. The overall mortality rate is comparable to other contemporary treatments, and is an important modality particularly in those with contraindications for adjunctive thrombolytic therapy. Further studies are needed to understand the interplay of anticoagulation with PT and catheter-directed thrombolysis.
[Efficacy of percutaneous mechanical thrombectomy for proximal deep vein thrombosis]. [2022]To study the efficacy and safety of percutaneous mechanical thrombectomy and long-term anticoagulation with rivaroxaban for proximal deep vein thrombosis.
Percutaneous mechanical thrombectomy for acute massive lower extremity deep venous thrombosis. [2016]To evaluate the clinical safety and effectiveness of percutaneous mechanical thrombectomy in patients with acute massive lower extremity deep venous thrombosis.
Aspiration thrombectomy using a large-size catheter for acute lower extremity deep vein thrombosis. [2022]This study retrospectively evaluated the safety and efficacy of aspiration thrombectomy using a large-size catheter for acute lower extremity deep vein thrombosis (DVT).
The Trellis Thrombectomy System in the treatment of acute limb ischemia. [2017]To report the use of a new percutaneous mechanical thrombectomy device in the treatment of acute limb-threatening ischemia.